BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MRP-7000(1) : 2-D INFLOW MR ANGIOGRAPHY

    K Number: K905834 · Decision Feb 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    1098
    Applicant Total
    10
    Review Days
    50

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    Basic Information

    Device Name
    MRP-7000(1) : 2-D INFLOW MR ANGIOGRAPHY
    K Number
    K905834
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1000
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Summit World Trade Corp.
    Date Received
    December 31, 1990
    Decision Date
    February 19, 1991
    Product Code
    LNH
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LNH System, Nuclear Magnetic Resonance Imaging

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    Other Clearances by Summit World Trade Corp.

    K Number Device Name
    K905833 MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY
    K905832 MRP -5000(1): VERSION 2.0 SOFTWARE
    K905835 MRP-7000: SUPPLEMENTAL R/F COILS
    K903318 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MOBILE MRP-30
    K903203 MRP-20: HS/MR HEAD COIL 3-D FT RECONSTRUCTION
    K903204 MRP-20: SUPPL R/F COIL HS/MR QUADRATURE HEAD COIL
    K901980 MOBILE MRP-20 MAGNETIC RESONANCE DIAGNOSTIC DEVICE
    K900919 MODIFIED HITACHI MRP-20 MAGNETIC RESONANCE DIAGNOS
    K894016 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MRP-20